Psychometric Validation (Quality-of-life Scale) in Young Women With a Non Metastatic Breast Cancer and Her Partner
KALICOU2
Psychometric Validation of a Subjective Quality-of-life Scale in Young Women With a Non Metastatic Breast Cancer and Her Partner (KALICOU 2 Protocol)
1 other identifier
observational
1,045
1 country
25
Brief Summary
- Selection of patient and preparation of questionnaires
- Presentation of the study by the doctor
- Verbal consent of participants (patient and Partner)
- Delivery of booklets
- Response to documents (questionnaires and written consent) at home, send by mail
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2010
Longer than P75 for all trials
25 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 11, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
November 27, 2013
CompletedFirst Submitted
Initial submission to the registry
August 3, 2016
CompletedFirst Posted
Study publicly available on registry
August 8, 2016
CompletedMarch 16, 2026
March 1, 2026
2.2 years
August 3, 2016
March 12, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Psychometric validation of a questionnaire in Young patients and their partners
1 year
Secondary Outcomes (2)
Compare convergent and or divergent dimensions with patients and theirs partners
1 year
Compare responses of participants according to treatment/ surveillance period
1 year
Study Arms (4)
Pending chemotherapy +/- trastuzumab
In the 1st group (chemotherapy), 25 couples will answer to kalicou questionnaire (KALI), 25 couples to KALI plus QLQC-30 and QLQBR-23 questionnaires for patients and SF-36 questionnaire for their partners. 25 couples will answer to KALI plus STAI plus CES-D questionnaires and 25 couples will answer twice to KALI questionnaire, with a delay of 15 days between each other
Pending trastuzumab +/- hormone therapy
In the 2nd group (trastuzumab), 25 couples will answer to kalicou questionnaire (KALI), 25 couples to KALI plus QLQC-30 and QLQBR-23 questionnaires for patients and SF-36 questionnaire for their partners. 25 couples will answer to KALI plus STAI plus CES-D questionnaires and 25 couples will answer twice to KALI questionnaire, with a delay of 15 days between each other
Pending hormone therapy alone
In the third group (hormone therapy), 25 couples will answer to kalicou questionnaire (KALI), 25 couples to KALI plus QLQC-30 and QLQBR-23 questionnaires for patients and SF-36 questionnaire for their partners. 25 couples will answer to KALI plus STAI plus CES-D questionnaires and 25 couples will answer twice to KALI questionnaire, with a delay of 15 days between each other
Pending aftercare period
In the last group (aftercare), 25 couples will answer to kalicou questionnaire (KALI), 25 couples to KALI plus QLQC-30 and QLQBR-23 questionnaires for patients and SF-36 questionnaire for their partners. 25 couples will answer to KALI plus STAI plus CES-D questionnaires and 25 couples will answer twice to KALI questionnaire, with a delay of 15 days between each other
Eligibility Criteria
Young women (\<45 years old)treated or previously treated by chemotherapy for a non metastatic breast cancer, in Relationship for at least 6 months
You may qualify if:
- \>18 years old (patient and partner)
- \<45 years old (patient)
- Patient with a non metastatic breast cancer
- Patient treated or previously treated by chemotherapy
- Patient and her Partner live together for at least 6 months when they complete the questionnaires.
You may not qualify if:
- Patient or partner with psychiatric trouble
- Native language other than french
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Oscar Lambretlead
- Université Lille 3collaborator
Study Sites (25)
Centre Marie Curie
Arras, 62000, France
Centre Pierre Curie
Beuvry, 62660, France
Centre François Baclesse
Caen, 14076, France
Clinique du Parc
Croix, 59963, France
Centre Léonard de Vinci
Dechy, 59187, France
Centre d'Oncologie Dunkerquois
Dunkirk, 59240, France
Centre Hospitalier de Saint Omer
Helfaut, 62570, France
Hôpital à Mignot
Le Chesnay, 78150, France
Centre Bourgogne
Lille, 59000, France
Centre Oscar Lambret
Lille, 59020, France
Groupe Hospitalier de l'Institut Catholique de Lille
Lille, 59020, France
Collège des Gynécologues
Marcq-en-Barœul, 59700, France
Service du Pr FAVRE - Hôpital de la TIMONE
Marseille, 13385, France
Centre Gray
Maubeuge, 59600, France
C.H.B.M.
Montbéliard, 25200, France
Centre Antoine LACASSAGNE
Nice, 06189, France
Institut du Cancer Courlancy Reims
Reims, 51100, France
Centre Eugène Marquis
Rennes, 35042, France
Centre Henri Becquerel
Rouen, 76038, France
Centre René GAUDUCHEAU
Saint-Herblain, 44805, France
Centre Joliot Curie
Saint-Martin-Boulogne, 62280, France
Clinique de la Victoire
Tourcoing, 59200, France
Clinique des Dentellières
Valenciennes, 59300, France
Centre Alexis VAUTRIN
Vandœuvre-lès-Nancy, 54500, France
Institut Gustave Roussy
Villejuif, 94805, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laurence VANLEMMENS, MD
Centre Oscar Lambret
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2016
First Posted
August 8, 2016
Study Start
January 11, 2010
Primary Completion
April 1, 2012
Study Completion
November 27, 2013
Last Updated
March 16, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share